FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
8593–8616 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 22, 1999
KVO CHECK VALVE ACCESSORY, MODEL EV-0001
K984441 · FPA
I-Flow Corp.
General Hospital · 70d
Cleared Feb 19, 1999
NITRILE POWDER FREE EXAMINATION GLOVES
K983334 · LZA
Cranberry (M) Sdn. Bhd.
General Hospital · 149d
Cleared Feb 19, 1999
BURETROL SOLUTION SETS
K984381 · FPA
Baxter Healthcare Corp
General Hospital · 73d
Cleared Feb 19, 1999
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDERED
K990081 · LYZ
Shanghai Palomar Mountain Industries,...
General Hospital · 39d
Cleared Feb 19, 1999
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
K990117 · LYZ
Shanghai Palomar Mountain Industries,...
General Hospital · 37d
Cleared Feb 19, 1999
GUTHRIE PRIME POWDER-FREE
K990228 · LYY
Guthrie Medicare Products (Melaka)...
General Hospital · 25d
Cleared Feb 18, 1999
LAGLOVE BRAND LATEX EXAMINATION GLOVE (POWDER FREE)
K990270 · LYY
La Glove (M) Sdn. Bhd.
General Hospital · 21d
Cleared Feb 18, 1999
LAGLOVE BRAND LATEX EXAMINATION GLOVES (LOW PROTEIN)
K990285 · LYY
La Glove (M) Sdn. Bhd.
General Hospital · 20d
Cleared Feb 17, 1999
POWDERED NITRILE EXAMINATION GLOVES
K984615 · LZA
Shiva Medicare , Ltd.
General Hospital · 50d
Cleared Feb 12, 1999
UP-GRADE AND UP-GRADE PRO
K983887 · FLL
Medisim, Ltd.
General Hospital · 102d
Cleared Feb 12, 1999
NBR 4 MILS, NITRILE EXAMINATION GLOVE NON-STERILE POWDERED
K984309 · LZA
Sumirubber Industries (Kedah) Sdn. Bhd.
General Hospital · 72d
Cleared Feb 12, 1999
CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED...
K990083 · FPA
Sims Deltec, Inc.
General Hospital · 32d
Cleared Feb 12, 1999
DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM
K990259 · FRN
Disetronic Medical Systems
General Hospital · 16d
Cleared Feb 10, 1999
SUPRASHIELD EXPRESS STERILIZATION WRAP
K990300 · FRG
Allegiance Healthcare Corp.
General Hospital · 9d
Cleared Feb 09, 1999
STERITITE PROCESS INDICATOR ACCESSORIES
K982151 · JOJ
Case Medical, Inc.
General Hospital · 236d
Cleared Feb 09, 1999
COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105,...
K983411 · FPA
Valnet Medical Corp.
General Hospital · 134d
Cleared Feb 09, 1999
LITE-TOUCH SYRINGE
K983430 · FMF
Medicore, Inc.
General Hospital · 133d
Cleared Feb 09, 1999
PARAGON BASAL/BOLUS ADMINISTRATION SET
K984063 · FPA
I-Flow Corp.
General Hospital · 85d
Cleared Feb 09, 1999
POWDERED LATEX EXAMINATION GLOVES, NON-STERILE
K984125 · LYY
Kilang Barangan Getah Dioh
General Hospital · 83d
Cleared Feb 09, 1999
PARAGON INFUSION
K984146 · FPA
I-Flow Corp.
General Hospital · 82d
Cleared Feb 09, 1999
NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE
K984311 · LZA
Sumirubber Industries (Kedah) Sdn. Bhd.
General Hospital · 69d
Cleared Feb 09, 1999
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K984460 · LYZ
Shanghai Huamao Gloves Co., Ltd.
General Hospital · 55d
Cleared Feb 09, 1999
PRE-POWDER VINYL PATIENT EXAMINATION GLOVES
K984461 · LYZ
Shanghai Huamao Gloves Co., Ltd.
General Hospital · 55d
Cleared Feb 09, 1999
POWDER FREE NITRILE EXAMINATION GLOVES
K984610 · LZA
Shiva Medicare , Ltd.
General Hospital · 42d